Wave Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Update

With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026

Combination and maintenance trials of WVE-007 on track to initiate in 2026

Data from RestorAATion-2 trial of WVE-006 (GalNAc-RNA editing) in AATD (including 400 mg monthly dose and 600 mg single dose cohorts) to be presented at an investor webcast during the ATS International Conference in May 2026

Regulatory feedback on accelerated approval pathway for WVE-006 continues to be expected mid-2026

CTA submission for WVE-008 (GalNAc-RNA editing for PNPLA3 I148M liver disease) on track for 2026

Well capitalized with cash and cash equivalents of $544.6 million as of March 31, 2026 and expected cash runway into 3Q 2028

Investor conference call and webcast at 8:30 a.m. ET today

CAMBRIDGE, Mass., April 28, 2026 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

“We’re accelerating WVE-007 to the next stages of development following the improvements in body composition already observed in the Phase 1 portion of our INLIGHT trial, including profound reductions in harmful visceral fat, along with favorable safety and potential for once to twice yearly dosing,” said Paul Bolno, MD, MBA, President and Chief Executive Officer at Wave Life Sciences. “This quarter, we expect to initiate the Phase 2a portion of INLIGHT in individuals with higher BMI and excess fat. Given WVE-007’s mechanism of targeted lipolysis, we believe this portion of the study can deliver even more pronounced improvements in body composition. Importantly, we’ve designed the Phase 2a study to assess additional biomarkers of cardiometabolic health, which will inform WVE-007’s broad potential across obesity and multiple indications, including MASH, type 2 diabetes, and cardiovascular disease. We also plan to rapidly initiate investigation of WVE-007 in both the combination and maintenance settings soon thereafter.”

Dr. Bolno added, “We continue to make significant progress advancing our RNA editing pipeline led by WVE-006 for AATD. Clinical data from our ongoing RestorAATion-2 trial of WVE-006 has already demonstrated the potential to provide a much-needed new therapeutic option. By correcting the root cause of disease, WVE-006 restores dynamic AAT production to address lung manifestations and lowers harmful Z-AAT to address liver manifestations of the disease, with a therapy that is well-tolerated, non-permanent, and highly specific. WVE-006 also avoids delivery with LNPs and collateral bystander edits and indels associated with DNA base editing. In May, we expect to highlight data from our RestorAATion-2 trial, including results from our less frequent, 400 mg monthly dose and 600 mg single dose cohorts. We remain on track to receive regulatory feedback on a potential accelerated approval pathway for WVE-006 mid-year. Building on our clinical success in RNAi and RNA editing, we are advancing WVE-008, as well as a pipeline of additional hepatic and extra-hepatic siRNAs and AIMers.”

Recent Business Highlights and Expected Milestones

Obesity

• WVE-007 is an investigational GalNAc-siRNA (SpiNA design) designed to silence INHBE mRNA to induce fat loss without muscle loss, a promising therapeutic strategy to treat obesity with strong evidence from human genetics. WVE-007 is being evaluated in the ongoing placebo-controlled INLIGHT clinical trial.
• Phase 1 INLIGHT: In March 2026, Wave announced interim results from the ongoing Phase 1, single-ascending dose portion of its INLIGHT trial in healthy individuals with overweight or obesity (average BMI of ~32 kg/m2, a population with less fat and lower BMI than those in Phase 2 and Phase 3 obesity studies), which showed further improvements in body composition at six months following a single dose of WVE-007. WVE-007 continued to be generally safe and well tolerated. At six-month follow-up, a single 240 mg dose of WVE-007 demonstrated continued total body fat reduction (-5.3%) with muscle preservation (+2.4%), as well as clinically meaningful reductions in visceral fat (-14.3%; p